Advagraf 3mg 100 Capsules

Product Description:

• Advagraf contains the active substance tacrolimus.
• It belongs to a group of medicines called immunosuppressants.
• After you have had an organ transplanted (liver, kidney), your body's immune system will try to reject the new organ. 
• Advagraf is used to control this immune reaction and help the body accept the transplanted organ.
• You can also receive treatment with Advagraf if you have a rejection reaction against a transplanted liver, kidney, heart or another organ, or if you have previously received other treatment that did not work against the immune reaction after the transplant.
• Advagraf is used in adults.

How To Use:

• Always use this medicine exactly as your doctor has told you. 
• Contact a doctor or pharmacist if you are unsure. 
• This medicine should only be prescribed for you by a doctor experienced in the treatment of transplant patients.
• Make sure you receive the same type of tacrolimus medicine each time you pick up your prescription, unless your transplant specialist has decided that you should switch to a different tacrolimus medicine. 
• This medicine should be taken once a day. 
• If the medicine does not look as usual, or if the instructions regarding dosage have changed, talk to your doctor or pharmacist as soon as possible to make sure that you have received the correct medicine.
• The starting dose given to prevent rejection of the transplanted organ is determined by the doctor and calculated based on your body weight.
• The first doses given soon after the transplant are usually in the range of 0.10-0.30 mg/kg body weight per day, depending on which organ has been transplanted. 
• When treating rejections, the same doses can be used.
• The dose depends on your general condition and which other immunosuppressive drugs you are taking. 
• After starting treatment with Advagraf, the doctor will take frequent blood tests from you to determine the correct dose. 
• The doctor will then regularly take blood tests to determine the correct dose and to adjust the dose from time to time.
• The doctor will usually reduce the dose of Advagraf as soon as your condition has stabilised.
• The doctor will give you exact information about how many capsules to take.
• You will need to take Advagraf every day for as long as you need immunosuppressive treatment to avoid rejection of the transplanted organ.
• You should keep in regular contact with your doctor.
• Advagraf should be taken once a day, in the morning. 
• Take Advagraf on an empty stomach or 2 to 3 hours after a meal. Wait at least 1 hour before your next meal.
• Take the capsules immediately after they are removed from the blister tray. 
• The capsules should be swallowed whole with a glass of water. 
• The desiccant in the foil package must not be swallowed.

If you take too much Advagraf:

• Contact a doctor or the nearest hospital/emergency room immediately if you have accidentally ingested too much Advagraf.

If you have forgotten to take Advagraf:

• If you have forgotten to take the Advagraf capsules in the morning, take them as soon as possible on the same day. 
• You should not take a double dose to replace a missed dose.

If you stop treatment with Advagraf:

• If you stop treatment with Advagraf, there may be an increased risk of the transplanted organ being rejected. 
• You must not stop the treatment without the doctor's advice.
• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Warnings And Precautions:

Do not use Advagraf:

• If you are allergic to tacrolimus or any of the other ingredients of this medicine.
• If you are allergic to sirolimus or other macrolide antibiotics (e.g. Erythromycin, clarithromycin, josamycin).
• Both Prograf and Advagraf contain the active substance tacrolimus.
• Advagraf is taken once daily.
• This is because Advagraf releases tacrolimus more slowly (slower release over a longer period).

Talk to your doctor or pharmacist before using Advagraf if:

• you use other medicines (specified under the section "Other medicines and Advagraf").
• you have or have had liver problems
• you have diarrhea for more than 1 day
• you have severe abdominal pain, whether accompanied by other symptoms or not, such as chills, fever , nausea or vomiting.
• You get a change in the heart's electrical activity called "QT prolongation"
• If you have or have had damage to the smallest blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura / haemolytic uremic syndrome.
• Tell your doctor if you develop a fever , bruising under the skin (which may look like red dots), unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urine output, vision loss and seizures.
• the risk of developing these symptoms may increase if tacrolimus is taken together with sirolimus or everolimus.
• Avoid using natural remedies, e.g. St. John's wort/st. John's wort ( hypericum perforatum ) or other herbal preparations, as this may affect the effect and size of the advagraf dose you need. 
• Talk to your doctor before taking natural remedies or herbal preparations, if you are in doubt.
• The doctor may find it necessary to adjust the dose of advagraf.
• You should keep in regular contact with the doctor. It may be that the doctor occasionally needs to carry out examinations of the blood, urine, heart and eyes in order to determine the correct dose of advagraf
• Avoid excessive exposure to sunlight or uv (ultraviolet) light while using advagraf.
• This is because immunosuppressive agents can increase the risk of skin cancer.
• Wear protective clothing and use sunscreen with a high sun protection factor.

Precautions for handling:

• Avoid the injection liquid, powder or granules from the tacrolimus products coming into direct contact with any part of the body, such as skin or eyes, or being inhaled during preparation.
• Wash the skin and eyes if such contact occurs.

Children and youth:

• The use of Advagraf is not recommended for children and adolescents under 18 years of age.

Other medicines and Advagraf:

• Talk to your doctor or pharmacist if you use or have recently used other medicines, this also applies to non-prescription medicines and natural remedies.
• The use of Advagraf at the same time as ciclosporin (another medicine used to prevent rejection of transplanted organs) is not recommended.
• If you see a doctor other than the transplant specialist, you should tell the doctor that you are using tacrolimus. 
• The doctor may need to consult the transplant specialist if you are going to use another medicine that can increase or decrease the concentration of tacrolimus in the blood .
• The amount of Advagraf in the blood can be affected by other medicines you take, and the amount of other medicines in the blood can be affected when you take Advagraf. 
• It may therefore be necessary to interrupt, increase or decrease the dose of Advagraf.
• Some patients have experienced that the tacrolimus concentration in the blood increases while taking other medicines.
• This can lead to serious side effects, such as kidney problems, problems in the nervous system and heart rhythm disturbances.
  The effect on the concentration of Advagraf in the blood can occur very quickly after you start using another medicine. 
• It may therefore be necessary to frequently monitor the Advagraf concentration in the blood from the first few days after you have started using another medicine, and beyond during treatment with the other medicine. 
• Some other medicines can cause the concentration of tacrolimus in the blood to decrease, which can increase the risk of rejection of the transplanted organ. 

You should especially inform the doctor if you are taking or have recently taken the following medicines:

• Antifungals and antibiotics, especially so-called macrolide antibiotics that are used to treat infections , e.g. Ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, caspofungin, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniazid and flucloxacillin
• Letermovir, used to prevent disease caused by cmv (human cytomegalovirus )
• HIV protease inhibitors (eg ritonavir, nelfinavir, saquinavir), the booster drug cobicistat and combination tablets, or non-nucleoside reverse transcriptase inhibitors (efavirenz, etravirine, nevirapine) , used to treat HIV infection.
• HCV protease inhibitors (eg telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir), used to treat hepatitis C – infection.
• nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide or mitotane (used to treat certain types of cancer ).
• Mycophenolic acid, which is used to suppress the immune system to prevent transplant rejection.
• Medicines to treat stomach ulcers and acid reflux (e.g. Omeprazole, lansoprazole or cimetidine)
• Antiemetics used to treat nausea and vomiting (eg metoclopramide)
• Cisapride or the magnesium/aluminium hydroxide antacid used to treat heartburn
• Birth control pills or other hormone therapy with ethinylestradiol, hormone therapy with danazol
• Medicines used to treat high blood pressure or heart problems (eg nifedipine, nicardipine, diltiazem and verapamil)
• Antiarrhythmic medicines (amiodarone) used to control arrhythmia (irregular heartbeat)
• Medicines known as " statins ", which are used to treat high cholesterol and fats (triglycerides)
• Carbamazepine, phenytoin or phenobarbital, used to treat epilepsy
• Metamizole, which is used to treat pain and fever
• The corticosteroids prednisolone and methylprednisolone, which belong to the group of corticosteroids , which are used to treat inflammation or to suppress the immune system (e.g. In transplant rejection)
• Nefazodone, which is used to treat depression
• Herbal preparations containing st. John's wort ( hypericum perforatum ) or extracts of schisandra sphenanthera
• Cannabidiol (used, among other things, for the treatment of seizures ).
• Tell your doctor if you receive treatment for hepatitis c. Drug treatment of hepatitis c can change your liver function and affect the concentration of tacrolimus in your blood. 
• The tacrolimus concentration in the blood may decrease or increase depending on which medicines have been prescribed for hepatitis c. 
• Your doctor may need to monitor tacrolimus blood levels closely and adjust your advagraf dose as needed after you start treatment for hepatitis c.
• Inform the doctor if you are taking or need to take ibuprofen (used to treat fever , inflammation and pain), antibiotics (cotrimoxazole, vancomycin or aminoglycoside antibiotics such as gentamicin), amphotericin b (used to treat fungal infections) or agents that act against viruses (used to treat viral infections, eg aciclovir, ganciclovir, cidofovir, foscarnet).
• These can worsen problems with the kidneys or nervous system if they are taken together with advagraf.

Tell your doctor if you are taking sirolimus or everolimus.

• The risk of developing thrombotic microangiopathy, thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome may be increased when tacrolimus is taken with sirolimus or everolimus.
• You should also tell your doctor if you are taking potassium supplements or certain diuretics used in heart failure, high blood pressure and kidney disease (eg amiloride, triamterene or spironolactone) or antibiotics such as trimethoprim or cotrimoxazole, which can increase potassium levels in the blood, at the same time as Advagraf , non-steroidal anti-inflammatory drugs ( NSAIDs , e.g. ibuprofen) used for fever , inflammation and pain, blood thinners or anti-diabetic drugs taken by mouth.
• If you need to receive a vaccine, you should tell the doctor this in advance.
• Taking Advagraf together with food and drink
• Avoid grapefruit (also as juice) when receiving treatment with Advagraf as it may affect the level in the blood.

Pregnancy and breastfeeding:

• Talk to your doctor before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant. 
• Advagraf passes into breast milk. 
• You should therefore not breast-feed while using Advagraf.
• Driving and using machines
• Do not drive or use tools or machines if you feel dizzy or sleepy or have trouble seeing clearly after taking Advagraf. 
• These reactions are more common if you also drink alcohol.

Advagraf contains lactose, sodium and lecithin (soy)

Advagraf contains lactose (milk sugar). 

• If your doctor has told you that you have an intolerance to (cannot stand) some types of sugar, you should contact your doctor before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per capsule, and is practically "sodium-free".
  The ink on the Advagraf capsules contains soy lecithin. 
• If you are allergic to peanuts or soy, talk to your doctor who will decide if you can use this medicine.

How to store Advagraf:

• Keep out of reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
• The expiration date is the last day of the specified month. 
• Use all prolonged-release capsules within 1 year after opening the aluminum bag.
• Store in the original packaging to protect against moisture.
• Medicines must not be thrown into waste water or together with household waste.
• Ask the pharmacy how to dispose of medicines that you no longer use. 
• These measures will help to protect the environment.

Ingredients:

DEPOT CAPSULES, hard 0.5 mg , 1 mg , 3 mg and 5 mg:

The active ingredient is tacrolimus.

• Each Advagraf 0.5 mg capsule contains 0.5 mg tacrolimus (as monohydrate)
• Each Advagraf 1 mg capsule contains 1 mg tacrolimus (as monohydrate).
• Each capsule of Advagraf 3 mg contains 3 mg tacrolimus (as monohydrate).
• Each capsule of Advagraf 5 mg contains 5 mg tacrolimus (as monohydrate).

What Advagraf looks like and the contents of the pack:

Advagraf 0.5 mg prolonged-release capsules:

• hard are hard gelatin capsules imprinted with “0.5 mg” in red on the light yellow upper part of the capsule and “ 647” on the orange lower part of the capsule. Contains white powder.
• Advagraf 0.5 mg comes in a blister tray or single-dose perforated blister with 10 capsules in a protective foil package that also contains a desiccant. 

Advagraf 1 mg prolonged-release capsules:

• hard are hard gelatin capsules imprinted with “1 mg” in red on the white upper part of the capsule and “ 677” on the orange lower part of the capsule.
• Contains white powder.
• Advagraf 1 mg comes in blister trays or single-dose perforated blisters with 10 capsules in a protective foil package that also contains a desiccant. 

Advagraf 3 mg prolonged-release capsules:

• hard are hard gelatin capsules imprinted with “3 mg” in red on the orange upper part of the capsule and “ 637” on the orange lower part of the capsule. Contains white powder.
• Advagraf 3 mg comes in blister trays or single-dose perforated blisters with 10 capsules in a protective foil package that also contains a desiccant.

Advagraf 5 mg prolonged-release capsules:

• hard are hard gelatin capsules imprinted with “5 mg” in red on the grey-red upper part of the capsule and “ 687” on the orange lower part of the capsule.
• Contains white powder.
• Advagraf 5 mg comes in blister trays or single-dose perforated blisters with 10 capsules in a protective foil package that also contains a desiccant.